OI Birmingham sort it out
shun and shame and boycott
#StandardOps
Octave duo
:(
About Octave
In 'Patients and public'
For the last year and a half around 4 million people in Britain have been strongly advised to ‘shield’ because they were at a great risk of severe illness and death if they were infected with COVID-19. Many of them have conditions such as cancer, inflammatory arthritis, kidney and liver disease. Their immune system may not be working at full strength due to their illness or the treatments they are receiving for their disease. Clinically-at-risk people were among the first in the UK to be offered one of the COVID-19 vaccines.
The rapid development of vaccines for COVID-19 has been a major step forward in the battle against this disease. Vaccines work by training the body’s immune system to fight a new disease. A national vaccination programme is underway for the vaccines approved by the UK regulatory authority. Prior to approval, the vaccines were tested on healthy volunteers but questions remain as to how well these vaccines will work in patients with these chronic illnesses.
The OCTAVE Trial
The OCTAVE trial is a multi-centre, multi-disease, prospective observational cohort trial. A team of researchers from universities and hospitals in England and Scotland has begun research, known as the OCTAVE study, to discover the effectiveness of the COVID-19 vaccine in these clinically at-risk patient groups. The researchers will build on years of experience in understanding the immune system in the context of chronic conditions. OCTAVE will help inform how best to vaccinate patients with chronic conditions, and protect them from COVID-19 infection in the future.
“We urgently need to understand if patient populations with chronic conditions such as cancer, inflammatory arthritis and kidney and liver disease are likely to be well-protected by current Covid-19 vaccines. The Octave study will give us invaluable new data to help us answer questions of this kind from our patients and their families.” Iain McInnes, Vice-Principal and Head of the College of Medical, Veterinary and Life Sciences at the University of Glasgow and Chief Investigator.
About the trial
The OCTAVE study will investigate the effectiveness of COVID-19 vaccines being used in the UK in 2021. Up to 5,000 people with certain immunosuppressed conditions will be involved. Using a variety of state-of-the-art immune tests performed on blood samples taken before and/or after COVID-19 vaccination, researchers will determine patients’ COVID-19 immune response and, therefore, the likelihood that vaccines will fully protect these groups from future COVID-19 infection. Researchers have begun recruiting patients at sites across the UK, and will compare results from the study group against control groups of healthy people without underlying diseases who have also received COVID-19 vaccines.
Participants with chronic kidney conditions, chronic liver conditions, inflammatory bowel disease, cancer, rheumatic or inflammatory conditions (e.g. rheumatoid arthritis), stem cell transplant and chimeric antigen receptor (CAR) T recipients attending specialist clinics across the UK will be recruited. The aim is to recruit 150participants in each of the disease types into Group 1 (which involves looking at the immune system response to COVID-19 in great detail) and an extra 850 participants in each of the disease types into Group 2 (which will conduct more simple laboratory tests to measure immune response). We will evaluate immune response in participants following receipt of regulatory approved vaccines in the UK.
What will happen to the results of the research trial?
When the study is complete the results will be published in a medical journal. We will also make a lay summary of the result available and publicise the results via patient groups, social media and the study website.
How to get involved
For more information on how to get involved, and for a list of which hospitals are currently recruiting patients to this trial, please visit our How to get involved page.
Find out how to get involved in the trial, and which hospitals are getting involved
Who can take part in the trial?
To be eligible to take part in the trial participants must:
have one of the healthcare conditions of interest i.e. breast cancer, lung cancer, acute myeloid leukaemia, multiple myeloma, rheumatic/inflammatory conditions, chronic renal conditions, chronic liver conditions, inflammatory bowel disease, or have received treatment with haematopoietic stem cell transplant (HSCT) or chimeric antigen receptor (CAR) T cells.
be eligible for vaccination and have not received the second dose of the vaccine (Group 1) or
have not passed 28 days after second dose of the vaccine (Group 2)
have an anticipated life expectancy of 6 months or more
Which hospitals are taking part in the trial?
Addenbrooke’s Hospital, Cambridge
Glasgow Royal Infirmary, Glasgow
Hammersmith Hospital, London
John Radcliffe Hospital, Oxford
King’s College Hospital, London
Queen Elizabeth Hospital, Birmingham
Royal Hallamshire Hospital, Sheffield
Southampton General Hospital, Southampton
St James’s University Hospital, Leeds
Participant Identification Centres (PIC)
Milton Keynes University Hospital NHS Foundation Trust
Royal Berkshire NHS Foundation Trust
Patient and Public Engagement
In 'Patients and public'
“By public involvement we mean research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them” - NIHR INVOLVE
It is essential that patients, and members of the public, are involved with the design and running of the OCTAVE trial. This ensures the best interests of patients are always at the forefront of researchers’ minds, and it provides valuable insights into patients’ experiences that help to shape the research.
Our Trial Management Group benefit greatly from patient representation with the involvement of Vicky Churchill and Elspeth Insch, who also helped with the review of the Patient Information Sheet.
"In regards to Covid-19 I am placed in the Clinically Extremely Vulnerable (CEV) category for people living with a serious underlying health condition. This has meant that throughout the pandemic my husband and me have been shielding and although we have both received the 2 doses of the vaccine we continue to shield as the effectiveness of the vaccines for people in the Clinically Vulnerable and Clinically Extremely Vulnerable groups is currently unknown. This is why this trial is so hugely important. It will help patients, their families, friends and the general public move forward for the future in living with the continuing existence of the Coronavirus.
For me, by being involved with the Trial Management Group, along with other Patient & Public Involvement and Engagement Groups, I find a positive to come out of not only my diagnosis but also living through this pandemic" Vicky Churchill
“I am honoured and excited to be involved with OCTAVE. As a patient with rheumatoid arthritis, I have been very aware of my vulnerability throughout the pandemic. I long to return to normal life but fear I am not yet safe. This important research will show the way forward, provide some reassurance and help protect those of us still at risk.” Elspeth Insch
Meet the research team
Meet the research team
In 'Participating sites'
Find out about our trial team and the roles they play
The OCTAVE Trial is coordinated by the Cancer Research UK Clinical Trials Unit (CRCTU) based at the University of Birmingham.
Chief Investigator has the overall lead researcher for a research project
Cohort Lead Investigators contribute to the OCTAVE Trial by deputising some of the Chief Investigator’s responsibilities for a specific cohort of the trial.
Trial Management Group (TMG) is a group of professionals from many different fields and organisations. The TMG meets several times a year in order to assist with overall management of the trial and to make important trial related decisions.
Access Committee (AC) established to ensure the appropriate governance of the research samples. Samples will be made available to academic researchers for ethically approved studies, subject to the approval of the Access Committee.
Principal Investigator at each of the hospitals running the OCTAVE Trial takes overall responsibility for ensuring that the trial is conducted correctly.
Chief Investigator: Professor Iain McInnes, Vice-Principal and Head of the College of Medical, Veterinary and Life Sciences at the University of Glasgow
Cohort Lead Investigators:
Cohort Lead InvestigatorsRheumatic/Inflammatory Diseases
Professor Iain McInnes and Professor Stefan Siebert, University of Glasgow
Cancer (Solid Tumours) Professor Pam Kearns and Professor Daniel Rea,
University of Birmingham
Cancer (Haematology)
Professor Gordon Cook, University of Leeds
Chronic Renal Disease
Dr Michelle Willicombe and Dr David Thomas,
Imperial College London
Chronic Liver and Inflammatory Bowel Disease
Professor Eleanor Barnes, Oxford University
Stem Cell Transplant
Dr Paul Miller, St George’s University Hospitals NHS Foundation Trust and
Dr Thushan de Silva, University of Sheffield
Laboratory lead:Professor Carl Goodyear, University of Glasgow
Other Co-Investigators:
Professor Doreen Cantrell, University of Dundee
Professor Ronjon Chakraverty, University College London
Professor Paul Klenerman, University of Oxford
Professor Gary Middleton, University of Birmingham
Professor Paul Moss, University of Birmingham
Professor Duncan Porter, University of Glasgow
Professor Alex Richter, University of Birmingham
Professor John Snowden, University of Sheffield
Dr Neil Basu, University of Glasgow
Dr Kim Orchard, University of Southampton
Miss Amanda Kirkham, University of Birmingham
Principal Investigators:
Professor Daniel Rea, Queen Elizabeth Hospital, Birmingham
Professor Stefan Siebert, Glasgow Royal Infirmary, Glasgow
Professor Gordon Crook, St James’s University Hospital, Leeds
Dr Michelle Willicombe & Dr David Thomas, Hammersmith Hospital, London
Professor Eleanor Barnes, John Radcliffe Hospital, Oxford
Dr Ram Malladi, Addenbrooke’s Hospital, Cambridge
Dr Kim Orchard, Southampton General Hospital, Southampton
Dr Robin Sanderson, King’s College Hospital, London
Professor John Snowden, Royal Hallamshire Hospital, Sheffield
Cancer Research UK Clinical Trials Unit (CRCTU) Trial Team:CRCTU Director of Operations Dr Sarah Bowden
Trial Management Team Leader Ms Sophia Magwaro
Senior Manager Mrs Ana Hughes
Trial Coordinator Mrs Molly Harrison
Trial Management Group:
Professor Eleanor Barnes, Chronic Liver and Inflammatory Bowel Disease Cohort Lead
Dr Sarah Bowden, CRCTU Director of Operations
Mrs Ana Hughes, CRCTU Senior Manager
Professor Carl Goodyear, Laboratory Lead
Miss Amanda Kirkham, CRCTU Trial Statistician
Ms Sophia Magwaro, CRCTU Trial Management Team Leader
Dr Paul Miller, Stem Cell Transplant Cohort Lead
Professor Daniel Rea, Cancer (solid Tumours) Cohort Lead
Professor Stefan Siebert, Rheumatic/Inflammatory Disease Cohort Lead
Dr Thushan de Silva, Stem Cell Transplant Cohort Lead
Dr David Thomas, Chronic Renal Disease Cohort Lead
Dr Michelle Willicombe, Chronic Renal Disease Cohort Lead
Professor Gordon Cook, Cancer (haematology) Cohort Lead
Professor Pam Kearns, CRCTU Director and Cancer (solid Tumours) Cohort Lead
Chair: Professor Iain McInnes, Chief Investigator and Rheumatic/Inflammatory Disease Cohort Lead
Secretariat: Mrs Molly Harrison, CRCTU Trial Coordinator
Access Committee:
Members TBC
Our funders and collaborators
In 'For Professionals'
Find out about who funds the trial and our collaborators.
Funder
The OCTAVE Trial is funded by the Medical Research Council
Collaborators
The trial is a collaboration between the University of Glasgow (Professor Iain McInnes the Chief Investigator is based here), The University of Birmingham (acting as Sponsor and delivering the trial) the University of Oxford, and Imperial College London. The trial is also supported and badged by the IMPACT network.
Trial documents
In 'Participating sites'
Download Trial Documentation (password protected)
Links to the trial’s current forms and documents are provided below. For any documentation that cannot be found on this page, please contact the OCTAVE Trial Office.
If there has been a recent amendment to the trial, please ensure that you have obtained R&D approval before using the updated versions of these documents.
Some of the documents on this page are large files. If you are having issues viewing the documents in your web browser, please right click and ‘Save link as…’ to read them in a PDF viewer such as Adobe Reader.
Trial protocol and supplementary documents
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the study. Patients who are interested in taking part in the study are advised to talk to their health care professional. Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.
Protocol (PDF, 1.40mb) You do not need a username and password to access this document
Protocol synopsis (PDF, 426kb)
Patient Documents
Patient information sheet and Informed consent form
PIS (PDF, 640kb)
ICF (PDF, 594kb)
GP letter (PDF, 579kb)
PIS and ICF Addendum (PDF, 604kb)
please note: all PIS, ICFs and GP Letters should be localised using hospital headed paper.
Other patient documents
Participant invitation letter (PDF, 463kb)
Participant ID card (PDF, 880kb)
Pharmacovigilance
SAE form (PDF, 739 kb)
SAE form completion guidelines (PDF, 559kb)
Investigational Medicinal Products Reg 174 Information For UK Healthcare Professionals
The latest Reg 174 Information For UK Healthcare Professionals for the Investigational Medicinal Products used in this trial are available below. Please ensure the latest versions are available in the Investigator Site File.
Reg 174 information Pfizer (PDF, 380kb)
Reg 174 Information Astra Zeneca (PDF, 146kb)
Reg 174 Information Moderna (PDF, 276kb)
Version control checklist
The version numbers and dates of all documents used for the trial are captured on the Investigator Site File Version Control List. Link to this Version Control List used in this trial is below.
Version control checklist (PDF, 18kb)
Sample collection
Lab manual (PDF, 1.56mb)
Samples handling manual (PDF, 1.47mb)
Lab forms
Labratory sample receipt (PDF, 359kb)
Octave sample tracker (Excel, 36kb)
Shipment manifest (Excel, 36kb)
Blood processing sheet for group 1 (PDF, 342kb)
Blood processing sheet for group 2 (PDF, 349kb)
Change of Staff
If there are any changes to the staff working on this trial, please complete the relevant staff Registration Form below. Please also ensure that the Site Signature and Delegation Log (SS&DL) is updated and return both documents to the OCTAVE Trial Office (via e-mail) link.
Site registration form (PDF, 33kb)
Investigator registration form (PDF, 520kb)
Staff registration form (PDF, 607kb)
Site signature & delegation log (PDF, 227kb)
Data collection
Serious adverse event form (PDF, 739kb)
Amended documents
Below are links to all of the amendments made to this trial that are relevant to all sites. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.
SA04 Amendment Rec Form (PDF, 104kb)
SA04 Amendment Tool (PDF, 343kb)
SA04 HRAHCRW Approval (PDF, 23kb)
SA04 MHRA Acceptence (PDF, 147kb)
SA04 Cover Letter REC (PDF, 227kb)
SA04 Cover Letter MHRA (PDF, 227kb)
SAM01 Amendment Tool signed (PDF, 314kb)
SAM01 Cover Letter MHRA (PDF, 230kb)
SAM01 Cover Letter Rec (PDF, 464kb)
SAM01 HRAHCRW Approval (PDF, 123kb)
SAM01 MHRA Acceptence (PDF, 141kb)
SAM01 Rec form (PDF, 503kb)
NSA01 Amendment Tool (PDF, 325kb)
NSA01 Cover Letter (PDF, 228kb)
For information about how we process your personal data, please view the Unit’s privacy notice.
Documents
In 'Patients and public'
This page will be updated with documents that may be helpful to patients and members of the public.
Lay Summary (PDF, 387kb)
Press releases
